Assessing the Contribution of Components in Late-Phase Oncology Trials: A Roadmap of Key Approaches [0.03%]
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Xiaowen Tian,Kristine Broglio,Di Ran et al.
Xiaowen Tian et al.
Systematic Review of Patient Focused Drug Development Meeting Reports for Conditions Affecting Neurodevelopment [0.03%]
针对影响神经发育疾病的以患者为中心的药物开发会议报告系统评价
Cristan Farmer,Victoria Kim,Tanvi Das et al.
Cristan Farmer et al.
Background: Researchers of rare diseases affecting neurodevelopment struggle with concept and outcome assessment identification issues that are uniquely associated with developmental concepts but common across conditions....
Mapping the evolution of cell and gene therapy product research: trends, collaborations, and emerging frontiers [0.03%]
绘制细胞和基因治疗产品研究的发展地图：趋势、合作和新兴前沿
Yanmei Rao,Li Dong,Zhe Huang
Yanmei Rao
Advanced therapeutic medicinal products represent a broad spectrum of biopharmaceutical innovations that prominently feature cell and gene therapy formulations. These cutting-edge therapeutic modalities are specifically engineered to interv...
Madhumitha Masilamani,Melvin George
Madhumitha Masilamani
Digital therapeutics (DTx) are emerging as a transformative approach in healthcare, offering software-driven, evidence-based interventions for the prevention, management, and treatment of medical conditions such as chronic diseases, mental ...
Applications and Challenges of Artificial Intelligence and Big Data in Drug Regulation [0.03%]
人工智能与大数据在药物监管中的应用及挑战
Zhao Liu,Yang Zheng,Jun Fang et al.
Zhao Liu et al.
Artificial intelligence (AI) and big data are increasingly applied in drug regulation and have demonstrated significant potential worldwide. The U.S. Food and Drug Administration (FDA) has developed a relatively comprehensive approach throu...
Metformin as an Adjunct in Periodontal Therapy: Mechanistic Insights, Research Evidence and Current Challenges [0.03%]
二甲双胍在牙周治疗中的辅助作用：机制见解、研究证据及当前挑战
Hamza Alasbily,Muna Saad Elburki
Hamza Alasbily
Periodontal disease is a chronic inflammatory disorder that gradually destroys tooth-supporting tissues including the alveolar bone, periodontal ligament, and cementum. In recent years, interest has grown in repurposing metformin, a well-kn...
The UK's 2026 Clinical Trial Regulations: A Strategic Analysis for Global Pharmaceutical Sponsors [0.03%]
英国2026年临床试验法规：全球制药企业的战略分析
Amer Alghabban
Amer Alghabban
The United Kingdom is undertaking the most significant reform of its clinical trials legislation in two decades with The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025. Set to come into full effect on 28 April 2026, ...
Estimand Framework Development for eGFR Slope Estimation and Comparative Analyses Across Various Estimation Methods [0.03%]
eGFR斜率估算及不同估计方法比较分析的估量框架开发
Tuo Wang,Yu Du
Tuo Wang
Chronic kidney disease (CKD) is a global health challenge characterized by progressive kidney function decline, often culminating in end-stage kidney disease (ESKD) and increased mortality. To address the limitations such as the extended tr...
A Survey on the Implementation of Analytical Quality by Design in Method Development in the Pharmaceutical Industries of Southeast Brazil: Challenges and Opportunities [0.03%]
巴西东南部制药行业中分析质量源于设计实施的调查：挑战与机遇
Bianca C Claro,Erica F Condado,Livia D Prado
Bianca C Claro
Analytical Quality by Design (AQbD) is a systematic approach that integrates quality into method design, ensuring robustness, fitness for purpose, and consistency throughout the lifecycle. This study aimed to assess the current scenario, be...
Innovative Multidimensional Quantitative Benefit-Risk Model for Effective Decision Making in Research and Development for Biopharmaceutical Industry [0.03%]
生物医药行业研发有效决策的创新型多维度定量风险收益模型
Maria E Verdugo,Fabio A Lievano,Melvin S Munsaka et al.
Maria E Verdugo et al.
Medicinal products have benefits and risks that must be carefully balanced to inform decision making. The structured benefit-risk (BR) framework is a powerful approach not only to standardize a holistic BR assessment, but also to incorporat...